This phase 1 study in Australia will evaluate the safety, reactogenicity and immunogenicity of the Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T) in children 2-\<6 years of age.
This Phase 1 randomized, placebo-controlled, observer-blind study will evaluate the safety, reactogenicity and immunogenicity of different formulations of SCB-1019T vaccine in children 2-\<6 years of age. A placebo is used as a control in the study because there is no licensed RSV comparator vaccine available for young children globally.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
The Kids Research Institute
Perth, Western Australia, Australia
Evaluate porportion of participants with solicied AEs of SCB-1019T vaccine
Porportion of participants with local and systemic solicied AEs
Time frame: Within 7 days after vaccination
Evaluate porportions of participants with unsolicited AEs of SCB-1019T vaccine
Porportions of participants with unsolicited AEs
Time frame: Within 28 days after vaccination
Evaluate porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study of SCB-1019T vaccine
Porportions of participants with SAEs, AESIs, MAAEs, AEs leading to early termination from the study
Time frame: Throughout the study period, from enrollment to 6 months follow up
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Bivalent Recombinant Respiratory Syncytial Virus (RSV) Vaccine (CHO Cell) (SCB-1019T)
0.9% NaCl saline placebo